3D Maternal Fetal Attachment and Smoking

Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby

Study Overview

• Status: Recruiting
• Conditions: Maternal-Fetal Relations; Maternal Behavior
• Intervention / Treatment: Behavioral: 3D printed model; Behavioral: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Cote, MD; Phone Number: 4023438511; Email: john.cote@alegent.org
• Study Contact Backup: Name: Caroline A Nubel, BPS; Phone Number: 4022804032; Email: carolinenubel@creighton.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Recruiting
      • Creighton University
      • Contact: Nicole Santek; Phone Number: 402-280-2322; Email: nicolesantek@creighton.edu
      • Sub-Investigator: Amy Badura Brack, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age - Female 19-45 years of age
• Fluent in English
• Currently smoking cigarettes
• Currently pregnant (between 21- and 36-weeks' gestation)
• Have normal 20-week ultrasound

Exclusion Criteria:

• Having received more than 3 ultrasounds prior to study
• Medical need for additional ultrasounds
• Multiple fetuses
• > 31 weeks gestation
• Does not smoke cigarettes
• Is not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D printed model; Mother is given 3D printed model of fetus' face	Behavioral: 3D printed model; Mother is given 3D printed model of fetus' face; Other Names: Mother is given 3D printed model of fetus' face
PLACEBO_COMPARATOR: Placebo; Mother is given printed picture of 3D ultrasound of fetus	Behavioral: Placebo; Mother is given a picture of 3D ultrasound of fetus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Antenatal Attachment Scale (MAAS)	The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)	5 minutes
The Timeline Follow Back (TLFB):	This semi-structured interview utilizes a calendar to aid in participants' recall of smoking throughout pregnancy. The TLFB method is the preferred approach to measure substance use and has shown reliability when used for pregnant women in previous studies	10 minutes
Salivary cotinine	Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.	5 minutes

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: John Cote, MD, Creighton University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2021
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2001287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No